{"operation":"document","citation":"21-0089","title":"Molecule Corp. Company — Hazardous Materials Safety Interpretation","source_type":"guidance","agency":"Pipeline and Hazardous Materials Safety Administration","status":"guidance","official":true,"published_on":"2021-12-10","effective_on":null,"summary":"21-0089 response to Molecule Corp. Company concerning 173.22.","machine_formats":{"json":"https://regulus.evalyn.ai/document/phmsa-interpretation-21-0089.json","markdown":"https://regulus.evalyn.ai/document/phmsa-interpretation-21-0089.md"},"app_url":"https://regulus.evalyn.ai/document/phmsa-interpretation-21-0089","source_url":"https://www.phmsa.dot.gov/sites/phmsa.dot.gov/files/docs/standards-rulemaking/hazmat/interpretations/76116/210089.pdf","body":"<<<PAGE 1>>>\n\nU.S. Department\nof Transportation\nPipeline and Hazardous\nMaterials Safety\nAdministration\n1200 New Jersey Avenue, SE\nWashington, DC 20590\nDecember 10, 2021\nMr. Nick Talken\nMolecule Corp. Company\nHenkel\n5110 Port Chicago Highway\nConcord, CA 94520\nReference No. 21-0089\nDear Mr. Talken:\nThis letter is in response to your August 23, 2021, letter requesting clarification of the Hazardous\nMaterials Regulations (HMR; 49 CFR Parts 171-180) applicable to hazardous materials\nclassification. You state that your company has developed a software data platform which\nprovides—for any new chemical formulation—the appropriate hazard classification and\ndescription. The output includes the UN Identification Number (UNID), hazardous materials\nshipping description, hazard class, and packing group (PG) as appropriate. The automatic\nassignment of hazard classification and description information is based on historical company\ndata (e.g., in-house testing data) and you provided further detail on how this function is\nperformed by the software. You seek feedback from this Office on your company’s software\napproach and technique for determination of hazard class and descriptions.\nIn accordance with § 173.22, it is the shipper’s responsibility to properly classify and describe a\nhazardous material. There is no prohibition in the HMR against using a software approach as part\nof the process to perform the functions of classifying and describing a hazardous material;\nhowever, a software approach cannot act as a substitute for the performance of testing in\ndetermining a hazard classification, where it is required. It is our understanding that your\nsoftware approach is an assistive tool and not a replacement for company testing in the absence\nof historical company test data that can be used as a comparison for a new formulation.\nTherefore, if your software approach—as described in your August 23, 2021, letter—provides\nthe hazard classification and material description in compliance with the requirements of the\nHMR and international regulations for the transport of hazardous materials, then we see no issue\nwith your company using this tool with regard to the shipper’s responsibility.\n\n<<<PAGE 2>>>\n\nPlease note, this response letter is neither a validation nor a certification of your software\napproach.\nI hope this information is helpful. Please contact us if we can be of further assistance.\nSincerely,\nDirk Der Kinderen\nChief, Standards Development Branch\nStandards and Rulemaking Division\n\n<<<PAGE 3>>>\n\nBaker\nFrom: Foster, Glenn (PHMSA)\nTo: Date: Dodd, Alice (PHMSA); Hillman, Kenetha CTR (PHMSA)\nSubject: FW: Henkel Company Correspondence\nMonday, August 30, 2021 12:23:15 PM\nAttachments: EO - Kelley(Henkel) 30Aug21.pdf\n21-0089\nAlice and Kenetha,\nPlease log this in as a request for a LOI and assign.\nThanks,\nGlenn\nFrom: Kelley, Shane (PHMSA) <shane.kelley@dot.gov>\nSent: Monday, August 30, 2021 12:20 PM\nTo: Foster, Glenn (PHMSA) <Glenn.Foster@dot.gov>\nSubject: FW: Henkel Company Correspondence\nCan we log this as an interp? I’d like to respond that we do not review software as a function of our\nOffice, but that automated methods of classification are acceptable provided that the resulting\nclassification is accurate and conforms to the requirements of the HMR. Something like that. Can\nbe short and sweet.\nFrom: Lisak, Frank (PHMSA) <frank.lisak@dot.gov>\nSent: Monday, August 30, 2021 12:00 PM\nTo: Kelley, Shane (PHMSA) <shane.kelley@dot.gov>\nSubject: Henkel Company Correspondence\nHi, Shane:\nThe attachment is for your review.\nI will keep the hardcopy in my locked cabinet until DOT resumes normal working hours.\nFrank\n\n<<<PAGE 4>>>\n\nAlbert - Open Letter to Department of Transportation - United States of America\nDate: August 23rd, 2021\nDirector, Standards and Rulemaking Division\nMr. Shane Kelley\nU.S. DOT/PHMSA (PHH-10)\nWashington, DC 20590\n1200 New Jersey Avenue, SE East Building, 2nd Floor\nDear Mr. Kelley,\nformulations and materials. Specifically, this data platform was built to capture structured data which can be used to accelerate innovation and\nOver the paşt 4 years, we have been developing a software data platform (called Albert) which facilitates our ability. to invent new chemical\nformulation and design of experiment, task management, reporting and visualization, and many more. However, the intent of this Open Letter is\nenhance collaboration between chemists or laboratories. Albert has many capabilities and functions, include chemical inventory management,\nto describe a specific feature of Albert that is related to the shipment of Hazardous Materials (HM) / Dangerous Goods (DG).\nfor each relevant transportation regulation (49 CFR, IATA, IMDG). The output of this classification includes: UN Number, Hazard Materials\nWithin the Albert platform, any chemist who has created a formulation can automatically receive the appropriate HM / DG Shipping Classification\nbased on all historical data within Albert, where the newly created formulation is compared to historical formulations, to ensure compliance with\nShipping Description, Hazard Class or Classes and Packing Group as appropriate. This automatic assignment of HM / DG shipping information is\nthe shipping regulations. The remaining content within this letter will describe in detail how this comparison and automatic assignment is done.\nHistorical Data:\nthe number of formulas which have been created, per Transportation method:\nWithin Albert, we have over 20 years worth of historical formulas that have been commercialized and shipped within the USA. Below you can see\nTransport Method\nCount of Unique Formulas\n49. CFR\n26449\nIATA\n29699\nIMDG\n30147\nyou can see the specific UN Numbers and Packing groups that are contained within this dataset. These Classifications were all performed\nFor all of these historical formulations, a Risk Assessment and HM / DG Classification was performed by a certified expert within Henkel. Below\nmanually by a certified Risk Assessment expert team, primarily located in Dusseldorf, Germany.\n*Classification Format: (UNnumber_PackingGroup)*\nTRANSPORT METHOD: CFR\n100000\n17852\n10000\n1461 1364\n1000\n872\n729\n654\nCount of Unique Formulas\n430\n302 271 263\n250\n217 211 175 168\n153\n152 146\n130\n130\n130\n100\n107\n100\n96\n86\n10\n1\nNot Regulated\nUN3082II\nUN1133_]1\nUN1993_1\nUN3264_|\nUN1814_1\nUN285 I\nUN1824,1\nUN3264_II\nUN2922 _II\nUN1139_1\nUN1823 _I\nUN2735_II\nUN3262_]I\nUN2735_]1\nUN1263_1\n÷ 1:\n→ 118G\nhe ture co\nClassification\n\n<<<PAGE 5>>>\n\nTRANSPORT METHOD: IATA\n100000\n19085\n10000\n3096\n1409 1198\n1000\n749\n510 477\nCount of Unique Formulas\n306 277 267\n258\n228 223\n177 172 165 154 151 133 133\n100\n132\n112 103 98\n86\n10\n1\nNot Regulated\nUN7264_1\n4UN3334II\nU280 I\nUN1824_\nUN3264 I\nUN1139.|\nUN2922_11\nUN1823_]|\nUN2235_II\nUN3262_JI\nUN2735_]!\nUN1993_!\nUN1760_1\nUN1719_\nUN279_|\nClassification\nTRANSPORT METHOD: IMDG\n100000\n21147\n10000\n1999 1462\n1000\n763\n707\n635\nCount of Unique Formulas\n306\n276 267 265\n230 225\n190\n177\n177 165\n163 142 134\n100\n131\n126 110\n96\n90\n82\n82\n10\n1\nNot Regulated\nUN1133_\"\nUN3264_||\nUN1950\nUN1814.1\nUN2922_\"\nUN3262,1\nUN2735 \"\nUN 1866_11\nUN3266_I|\nClassification\nAutomatic Generation of Classification for New Formulas:\nAlgorithm Similarity:\nfactors, including GHS classification, Flash Point, Reaction Exotherm, Product Type, State of Matter, Chemical Composition, and others. The\nIt is very important to understand how the similarity is determined by the above mentioned Algorithm. This similarity is a combination of many\npurpose of the Algorithm is to determine the best combination of factors (mentioned above) which allow for the closest formula comparison.\nValidation of Algorithm:\n\n<<<PAGE 6>>>\n\ndata. First, we split the historical data into 2 partitions, with 80% in the \"training set\" and 20% in the \"test set\". For each of the transportation\nIn order to ensure this method of \"lookup\" is accurate for a wide variety of new potential formulas, we performed statistical testing on the historical\nDG classification to the actual classification from the \"test set\". The results of this test ensures complete accuracy across all historical and new\nmethods, we took the \"test set\" and used algorithm with the \"training set\" to determine the HM / DG classification. We then compared this HM /\ndata.\nWe understand that compliance with these regulations is paramount at all times from the beginning to end of the classification and transport cycle.\nOpen Questions:\n1. Based on the information provided, assuming the above information is accurate, we would like to solicit any input from the Department\non our approach.\n2. Please provide any other feedback on our software driven approach and techniques.\n3. Please provide your position on our methods stated above, given that it has been shown to be more accurate than manual classification.\nThank you and we look forward to your response.\nSincerely,\nNick Talken\nKen Kisner\nHead of Albert Data Platform\nHead of Digital Innovation\nnick.talken@henkel.com\nken.kisner@henkel.com\n(925) 381-6796\nNick Talken\n(925) 381-1253\nKen D. Kisner","truncated":false,"body_characters":9026}